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Labomed

by Labotech Microscopes India Pvt. Ltd. India EUDAMED

Ref 6181001Model 6138000 EMDN Z12011101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8908006463613-PR-DNTNJ Basic UDI-DIDate25 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Prima DNT - Dental Microscope Mobile mount
Model / Reference
6138000, 6181001
Primary DI / UDI-DI
08908006463640
Basic UDI-DI
8908006463613-PR-DNTNJ
Direct Marketing DI
08908006463640
EMDN Code
Z12011101 Operative microscopes
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
IN-MF-000033373
Authorised representative
Labomed Europe b.v. NL-AR-000022889

Other devices from Labotech Microscopes India Pvt. Ltd.

See all devices from Labotech Microscopes India Pvt. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 1d010989-b88c-4655-913f-22ef111b6160 61 fields · synced 25 Oct 2026